Tonix Pharmaceuticals Receives Fast Track Designation from the U.S. FDA for TNX-102 SL for Treatment of Agitation in Alzheim...
July 16 2018 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), today
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation to its investigational new drug,
TNX-102 SL, for the treatment of agitation in Alzheimer’s disease.
The same drug, TNX-102 SL, or Tonmya®*, for the treatment of
posttraumatic stress disorder (PTSD), has previously been
designated as a Breakthrough Therapy by the FDA. It is
currently in a Phase 3 study for military-related PTSD, with an
interim analysis expected in the third quarter of 2018.
Fast track is a process designed to facilitate the development
and expedite the review of drugs to treat serious conditions and
fill an unmet medical need. The benefits of a Fast Track
designation include rolling submission of portions of the New Drug
Application (NDA) for the drug candidate and eligibility for
priority review of the NDA. Additionally, more frequent meetings
and written communication with the FDA regarding the development
plan and trial design for the drug candidate are encouraged
throughout the entire drug development and review process, with the
goal of having earlier drug approval and access for patients.
“Fast Track designation reflects the recognition by the FDA that
TNX-102 SL has the potential to address a large unmet medical need
for a serious condition,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix. “Currently, there are no FDA-approved treatments
for agitation in Alzheimer’s disease, despite a high disease burden
and a need for an effective therapy. We are eager to work closely
with the FDA to advance the development TNX-102 SL for the
treatment of agitation in Alzheimer’s disease."
Tonix received clearance of the Investigational New Drug
Application, or IND, from the FDA for TNX-102 SL 5.6 mg in April of
this year which supports the initiation of a Phase 2, potential
pivotal efficacy study of TNX-102 SL in patients with agitation in
Alzheimer’s disease. In addition to evaluating the safety and
efficacy of TNX-102 SL after 8 weeks of bedtime treatment, the
Phase 2 study will analyze genomic DNA to identify biomarkers that
may be associated with treatment response.
* Tonmya has been conditionally accepted by the FDA as the
proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual
tablets) for PTSD. TNX-102 SL is an investigational new drug and
has not been approved for any indication.
About Agitation in Alzheimer’s Disease
Agitation in Alzheimer’s disease, which includes emotional
lability, restlessness, irritability, and aggression, is one of the
most distressing and debilitating of the behavioral complications
of Alzheimer’s disease. Agitation in Alzheimer’s disease has
significant negative consequences for patients as well as their
caregivers and is one of the most common reasons for patients
having to transition to nursing homes and other long-term care
settings. Agitation is likely to affect more than half of the 5.3
million Americans who currently suffer from Alzheimer’s disease,
and this number is expected to nearly triple by 2050. The presence
of agitation nearly doubles the cost of caring for patients with
Alzheimer’s disease, and agitation is estimated to account for more
than 12 percent of the $256 billion in healthcare and societal
costs associated with Alzheimer’s disease for the year 2017 in the
United States. Currently, there is no FDA approved treatment for
behavioral symptoms in Alzheimer’s disease such as agitation and
aggression. There is widespread off-label use of atypical
anti-psychotic medications for these behavioral symptoms, despite
the lack of evidence for their effectiveness and significant
medical risks associated with their use in this population.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing pharmaceutical products to treat serious
neuropsychiatric conditions and biological products to improve
biodefense through potential medical counter-measures. Tonix’s lead
product candidate, Tonmya, or TNX-102 SL, is a Breakthrough Therapy
in Phase 3 development as a bedtime treatment for PTSD. Tonix is
also developing TNX-102 SL, which has been granted Fast Track
designation by the FDA, as a bedtime treatment for agitation in
Alzheimer’s disease under a separate IND to support a Phase 2,
potential pivotal, efficacy study. TNX-601 (tianeptine oxalate) is
in the pre-IND application stage, also for the treatment of PTSD
but by a unique mechanism and designed for daytime dosing. Tonix’s
lead biologic candidate, TNX-801, is a potential
smallpox-preventing vaccine based on a live synthetic version of
horsepox virus, currently in the pre-IND application stage.
This press release and further information about Tonix can be
found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of
forward-looking words such as “anticipate,” “believe,” “forecast,”
“estimate,” “expect,” and “intend,” among others. These
forward-looking statements are based on Tonix's current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations; our need for additional financing;
uncertainties of patent protection and litigation; uncertainties of
government or third party payor reimbursement; limited research and
development efforts and dependence upon third parties; and
substantial competition. As with any pharmaceutical under
development, there are significant risks in the development,
regulatory approval and commercialization of new products. Tonix
does not undertake an obligation to update or revise any
forward-looking statement. Investors should read the risk factors
set forth in the Annual Report on Form 10-K for the year ended
December 31, 2017, as filed with the Securities and Exchange
Commission (the “SEC”) on March 9, 2018, and periodic reports filed
with the SEC on or after the date thereof. All of Tonix's
forward-looking statements are expressly qualified by all such risk
factors and other cautionary statements. The information set forth
herein speaks only as of the date thereof.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Scott Stachowiak (media)Russo
Partnersscott.stachowiak@russopartnersllc.com (646) 942-5630
Peter Vozzo (investors)Westwicke
Partnerspeter.vozzo@westwicke.com (443) 213-0505
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